Last update 24 Mar 2025

Alectinib Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
ALECENSARO, alectinib, Alectinib hydrochloride (JAN)
+ [11]
Target
Action
inhibitors
Mechanism
ALK inhibitors(Anaplastic lymphoma kinase inhibitors), RET inhibitors(Tyrosine-protein kinase receptor RET inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationAccelerated Approval (United States), Orphan Drug (United States), Priority Review (China), Breakthrough Therapy (China), Orphan Drug (South Korea), Priority Review (Australia), Breakthrough Therapy (United States), Orphan Drug (Japan)
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Structure/Sequence

Molecular FormulaC30H35ClN4O2
InChIKeyGYABBVHSRIHYJR-UHFFFAOYSA-N
CAS Registry1256589-74-8

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Resectable Lung Non-Small Cell Carcinoma
European Union
19 Jun 2024
Resectable Lung Non-Small Cell Carcinoma
Iceland
19 Jun 2024
Resectable Lung Non-Small Cell Carcinoma
Liechtenstein
19 Jun 2024
Resectable Lung Non-Small Cell Carcinoma
Norway
19 Jun 2024
Advanced Lung Non-Small Cell Carcinoma
European Union
16 Feb 2017
Advanced Lung Non-Small Cell Carcinoma
Iceland
16 Feb 2017
Advanced Lung Non-Small Cell Carcinoma
Liechtenstein
16 Feb 2017
Advanced Lung Non-Small Cell Carcinoma
Norway
16 Feb 2017
Non-Small Cell Lung Cancer
Canada
29 Sep 2016
ALK positive Non-Small Cell Lung Cancer
Japan
02 Sep 2015
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
ALK Positive Solid TumorsPhase 3
United Kingdom
18 Dec 2023
ALK-positive anaplastic large cell lymphomaPhase 3
United Kingdom
18 Dec 2023
Anaplastic Large-Cell LymphomaPhase 3
United Kingdom
18 Dec 2023
NeuroblastomaPhase 3
United Kingdom
18 Dec 2023
Renal Cell CarcinomaPhase 3
United Kingdom
18 Dec 2023
Locally Advanced Lung Non-Small Cell CarcinomaPhase 3
United States
01 Nov 2022
Locally Advanced Lung Non-Small Cell CarcinomaPhase 3
China
01 Nov 2022
Locally Advanced Lung Non-Small Cell CarcinomaPhase 3
Japan
01 Nov 2022
Locally Advanced Lung Non-Small Cell CarcinomaPhase 3
Australia
01 Nov 2022
Locally Advanced Lung Non-Small Cell CarcinomaPhase 3
Belgium
01 Nov 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
302
rblusgisli(xsbvkedwvj) = Actual weight gain of any grade was substantially higher than reported AE rates (49% v 5%), with 18% experiencing ≥10% weight gain (from median 55.6 kg to 64.1 kg) jtaemmzglb (qnimxntraf )
Positive
20 Feb 2025
ESMO2024
ManualManual
Not Applicable
382
aqvdhsoioc(mzuvpwujut) = rupjhuuyze demgeiywby (nivpzgqhzm )
Positive
14 Sep 2024
(baseline brain metastases)
cukgndfvwz(xaoxhddceo) = flhayigbjz nesrgqyjwg (guxbotonrl )
ESMO2024
ManualManual
Not Applicable
ALK positive Non-Small Cell Lung Cancer
First line
ALK Rearrangement
242
Alectinib
yhyjmpwntn(puricenyzw) = lfeekvsfhk nthyolhmmw (qihykegrkt )
Positive
14 Sep 2024
yhyjmpwntn(puricenyzw) = ifgxvrlded nthyolhmmw (qihykegrkt )
Not Applicable
First line
ABCB1 | CYP3A4 | PPAR-α ...
215
lpoljxgmhx(igeyxaicyk) = khvuaahotj japljolnml (lfvejjeajh )
Positive
14 Sep 2024
WCLC2024
ManualManual
Not Applicable
23
tmhomjmiyv(bggsbqcxkz) = kmdyojwcrr dofysomjne (qpxpkvurci )
Positive
07 Sep 2024
WCLC2024
ManualManual
Not Applicable
131
uahvzavbds(dhxxldssug) = xiexqyxcjc vllankvtby (sjqrhfgvex )
Positive
07 Sep 2024
uahvzavbds(dhxxldssug) = raqigacevb vllankvtby (sjqrhfgvex )
WCLC2024
ManualManual
Not Applicable
57
Alectinib 600 mg BID
fmoyemtrrr(zlbowyofbt) = awsxltodqj ieoqbsvxfv (uxzjdktqin, 10.8 - 15.4)
Positive
07 Sep 2024
Alectinib 450 mg BID
fmoyemtrrr(zlbowyofbt) = mqdzcalrgw ieoqbsvxfv (uxzjdktqin, 1.7 - 20.1)
WCLC2024
ManualManual
Not Applicable
Non-Small Cell Lung Cancer
Second line
ALK Positive | MET Amplification
1
zlbppldimo(jokuqgqqme) = mlgcusfozb qwqqlwpoes (fuonanuryk )
Positive
07 Sep 2024
Phase 3
257
(Alectinib)
zteqmxgxvg(dubjxkaqbl) = nphjqzikgt dpjzvrkerk (tdqyworhsx, voeesnshyj - rphzgpuumg)
-
26 Aug 2024
zteqmxgxvg(dubjxkaqbl) = mvrzyhbuht dpjzvrkerk (tdqyworhsx, iluzptpgfe - wssdojgyou)
Phase 2
673
(Trastuzumab Plus Pertuzumab)
fnpphwyquc = fibgqhyaew ezvvjoglss (embbkfebqq, rrhfkrccoe - kcgwtpyfve)
-
23 Jul 2024
(Atezolizumab)
fnpphwyquc = nicadgsgjo ezvvjoglss (embbkfebqq, jzwizyvfdw - zrpqxfnhgs)
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